FDA Issues New Standards for Diet Supplements

The Food and Drug Administration has delivered long-delayed rules on how diet supplements are manufactured, packaged and labeled. Critics say that the rules may help a little, but there is still no evidence that the widely used products are completely safe or effective.

But first, the Food and Drug Administration yesterday issued long-delayed rules on how diet supplements are manufactured, packaged and labeled. Critics say that while the rules may help a little, there's still no evidence that the widely used products are completely safe or effective.

NPR's Julie Rovner reports.

JULIE ROVNER: In 1994, Congress passed the Dietary Supplement Health and Education Act, better known as DSHEA. The law actually limited FDA's ability to regulate vitamins, minerals and herbal remedies. The agency was to treat them more like food and less like drugs.

But Congress did order the agency to establish so-called good manufacturing practices. Those were to ensure that supplement makers produce products free from contamination, products that actually contain what's on their label.

Yesterday, 13 years after the law was passed, the FDA issued those rules. Utah Republican Senator Orrin Hatch, one of DSHEA's lead sponsors, said it was about time.

Senator ORRIN HATCH (Republican, Utah): DSHEA called for FDA to publish these GMPs to help assure the dietary supplements are produced in a sanitary and wholesome fashion. And as far as I'm concerned, this is the frontline of assault against unsafe or improperly manufactured products.

ROVNER: Groups representing the supplement industry also welcomed the rules. Andrew Fish of the Consumer Healthcare Products Association said his members already meet all the new requirements. What's different, he says, is that the rules can help the agency prevent potential problems rather than respond after problems are reported.

Mr. ANDREW FISH (Senior Vice President, Legal and Government Affairs, Consumer Healthcare Products Association): Now what FDA has the ability to do is to go into a manufacturer's operations and ensure that they're, in fact, doing everything they should be doing step by step.

ROVNER: But others aren't so sure that the rules will fix what ails the diet supplement industry, which now sells more than $21 billion worth of products to more than 100 million Americans each year. Tod Cooperman is president of ConsumerLab.com, which independently tests many of those supplements.

Dr. TOD COOPERMAN (President, ConsumerLab.com): ConsumerLab.com has been testing dietary supplements since 1999 and we have found that one out of four supplements have some type of quality problem.

ROVNER: Problems like having too much or too little of its labeled ingredient or, even more dangerous, products contaminated with lead or insecticides. Cooperman says the new rules are a step in the right direction, but they have too many loopholes.

Dr. COOPERMAN: For example, there is no standard in this new GMP for purity of supplements, how much lead is acceptable in a supplement? You know, it should be a very, very minute amount; There is no limit; It's left to the manufacturer to decide.

ROVNER: But the biggest problem, says Janell Duncan of Consumers Union, is that unlike drugs, diet supplements don't have to prove they work before they're allowed on the market.

Ms. JANELL DUNCAN (Senior Counsel, Consumers Union): With a drug, there's been showing made that the product will help more consumers than it will hurt and the benefit will outweigh any risks. There's no such showing for dietary supplements. And so there may be products out there that have a benefit, but are just way too risky for what a consumer gets.

ROVNER: Meanwhile, the new rules take effect for large firms in August. The smallest firms have as long as three more years to come into compliance.

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